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First device to treat migraine wins FDA approval

The Cerena Transcranial Magnetic Stimulator, the first medical device for the treatment of
migraine headaches preceded with aura, has won regulatory approval in the United States.

On Friday, the US Food and Drug Administration (FDA) announced it had allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS),
manufactured by eNeura Therapeutics of Sunnyvale, CA, for use under prescription, for the relief of pain caused
by migraines that are preceded by an aura.

Migraine affects one in 10 people worldwide

A migraine is an intense pulsing or throbbing pain in part of the head, accompanied by nausea and sometimes
vomiting, plus heightened sensitivity to light and sound. The debilitating condition can last from 4 up to 72
hours if not treated.

Migraines affect one in 10 people worldwide, with women three times more likely to experience them than
men. Around one in three migraine sufferers also experiences an aura - a visual sensory or motor disturbance
that precedes the headache itself.

Researchers claim that a pulse of magnetic energy may hold the key to migraine relief - a condition that affects three times as many women as men.

The operas of the German composer Richard Wagner are thought to reflect the influence of his disabling
migraine headaches.

The Cerena TMS, which is available on prescription only, is used after the pain of migraine preceded with
aura has started.

The patient holds the device with two hands against the back of the head. When they press a button, it
releases a pulse of magnetic energy through the skull into the occipital cortex. The idea is that by
stimulating this part of the brain, the pulse either lessens or stops the pain.

The FDA reviewed pre-market data and the results of a clinical trial of the Cerena TMS

The FDA notes in its announcement that it "reviewed the data for the Cerena TMS through the de novo
pre-market review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not
substantially equivalent to an already legally marketed device."

A randomized controlled trial of 201 patients showed that nearly 38% of those using the TMS when they had
migraine were pain-free for 2 hours after, compared with 17% of the controls.

After 24 hours, 34% of the TMS users were pain-free compared with 10% of the controls.

The trial did not find that the device effectively relieves symptoms associated with migraine, such as
sensitivity to light and sound, or nausea.

The device is for patients aged 18 and over and recommended daily use should not exceed one treatment in 24
hours, says the FDA.

Patients who have magnetic metals in the head, neck or upper body must not use the device, and neither must
people with pacemakers, deep brain stimulators, or other forms of implanted devices.

Patients with suspected or diagnosed epilepsy or a personal or family history of seizures should also not
use the device.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and
Radiological Health, says:

"Millions of people suffer from migraines and this new device represents a new treatment option for some
patients."

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